ID
41481
Description
Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 This Form has to be filled in at the Followup Visit. It records Vital Signs, changes from the Post-Treatment Exam and (re)occurence of specified Events.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (1)
- 10/24/20 10/24/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 24, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
30-Day Followup (+/- 14 Days)
- StudyEvent: ODM
Description
Followup Visit
Alias
- UMLS CUI-1
- C0589121
Description
Telephone call replacing visit
Data type
text
Alias
- UMLS CUI [1,1]
- C0302186
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0545082
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C3694716
Description
(0000-2359)
Data type
time
Alias
- UMLS CUI [1,1]
- C0589121
- UMLS CUI [1,2]
- C0040223
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Blood pressure - systolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure - diastolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Respiratory rate
Data type
integer
Measurement units
- per min.
Alias
- UMLS CUI [1]
- C0231832
Description
Heart rate
Data type
text
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Body temperature
Data type
float
Alias
- UMLS CUI [1]
- C0005903
Description
Body temperature unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Body system examined
Data type
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C0031809
Description
(one per line)
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0678257
- UMLS CUI [1,3]
- C0443172
Description
No change in physical examination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0442739
- UMLS CUI [1,2]
- C0031809
Description
Please mark all events that occurred during dosing:
Alias
- UMLS CUI-1
- C2347784
Description
If None, check this Box and leave the following fields blank.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347784
- UMLS CUI [1,2]
- C0549184
Description
Venous thrombosis
Data type
text
Alias
- UMLS CUI [1]
- C0042487
Description
Venous thrombosis - location
Data type
text
Alias
- UMLS CUI [1,1]
- C0042487
- UMLS CUI [1,2]
- C0450429
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0042487
- UMLS CUI [1,2]
- C0011008
Description
Pulmonary embolus
Data type
text
Alias
- UMLS CUI [1]
- C0034065
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0011008
Description
Arterial thrombosis
Data type
text
Alias
- UMLS CUI [1]
- C0151942
Description
Arterial thrombosis - location
Data type
text
Alias
- UMLS CUI [1,1]
- C0151942
- UMLS CUI [1,2]
- C0450429
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0151942
- UMLS CUI [1,2]
- C0011008
Description
Clotting in external circuit that requires immediate intervention
Data type
text
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
Description
Clotting in external circuit that requires immediate intervention - specify circuit location
Data type
text
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
- UMLS CUI [3,1]
- C2348235
- UMLS CUI [3,2]
- C0015354
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
- UMLS CUI [3]
- C0011008
Description
Death due to thromboembolic complication
Data type
text
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
- UMLS CUI [1,4]
- C1148348
Description
Amputation due to thromboembolic complication
Data type
text
Alias
- UMLS CUI [1,1]
- C0002688
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0002688
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
- UMLS CUI [1,4]
- C0011008
Similar models
30-Day Followup (+/- 14 Days)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3,1])
C0015354 (UMLS CUI [3,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C1148348 (UMLS CUI [1,4])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])